The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Ib Drill.
| Device ID | K911937 |
| 510k Number | K911937 |
| Device Name: | OSTEOMED IB DRILL |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Contact | Rich A Buss |
| Correspondent | Rich A Buss OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-01 |
| Decision Date | 1991-06-10 |